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Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00114686
Recruitment Status : Completed
First Posted : June 17, 2005
Last Update Posted : January 4, 2013
Information provided by:

Brief Summary:
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Alcohol Dependence Drug: Quetiapine fumarate Drug: lithium Drug: divalproex Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder
Study Start Date : January 2006
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale

Secondary Outcome Measures :
  1. Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
  2. Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets criteria for Bipolar I Disorder with Alcohol dependence
  • Outpatient Status
  • Recent history of heavy drinking

Exclusion Criteria:

  • Unstable medical illness
  • Recent antipsychotic use
  • Poorly controlled Diabetes Mellitus or Diabetes related illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114686

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Sponsors and Collaborators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00114686     History of Changes
Other Study ID Numbers: D144AL00002
First Posted: June 17, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
Bipolar I Disorder
Alcohol Dependency

Additional relevant MeSH terms:
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Quetiapine Fumarate
Lithium Carbonate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents